MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p provided in the published literature.Concomitant medical products: product id: neu_enterra_ins, lot#: unknown, product type: implantable neurostimulator.Product id: neu_unknown_lead, lot#: unknown, product type: lead.Product id: neu_enterra_ins, lot#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Corvinus, f.M, heinrich, s., neumann, h., neumann, h., hadzijusufovic, e., babic, b., lang, h., grimminger, p.P.Minimal-invasive temporary gastric stimulation: a pilot study to predict the outcome of electronic gastric stimulation with the enterra system.Dig liver dis.2018.Doi: 10.1016/j.Dld.2018.05.023 summary: gastroparesis (gp) is defined as delayed gastric emptying (ge) without any obstruction of the pylorus.It can be divided into idiopathic, diabetic, post surgical and rare causes.Electronic gastricstimulation (egs) ¿ enterra medtronictm¿ is a part of gp therapy.Although its positive impact has been reported in open label trials, randomized controlled trials failed in demonstrating a positive outcome.The aim of this pilot study was to establish a reliable prediction for permanent gastric stimulation.Patients and procedure: 6 female patients underwent laparoscopic implantation of 2 temporary electrodes.The enterratm system was connected and taped to the skin.Baseline and postoperative gastroparesiscardinal symptom index (gcsi), a validated index for gp therapy, was assessed.Response to egs was defined as a 50% decrease of baseline gcsi.Results: 4 of 6 patients responded to temporary egs.3 of 4 responders underwent permanent implantation.1 non-responder received a permanent enterratmat another institution.After a median follow-up time of 9 months the responder group gcsi remained low, whereas the non-responder gcsi had increased.Moreover, the health care system was saved d 30,678.03 by this test stimulation concept.Conclusion: laparoscopic implantation of a temporary egs system predicts the outcome of permanent gastric stimulation and is cost-saving.Reported events: one patient had a dislocation of an electrode after 30 days of stimulation.At that time the patient had already fulfilled the responder criteria of 23 days.No specific device information provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEU_ENTERRA_INS
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis,mn, MA 55432 ; 7635263920
• MDR Report Key: 8151105
• MDR Text Key: 130060973
• Report Number: 3007566237-2018-03558
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 07/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1